Application 065382
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLARITHROMYCIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 125MG/5ML | No | No |
| 002 | CLARITHROMYCIN | CLARITHROMYCIN | FOR SUSPENSION;ORAL | 250MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065382-001 | CLARITHROMYCIN | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | ||
| A065382-002 | CLARITHROMYCIN | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065382-001 | CLARITHROMYCIN | 125MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065382-002 | CLARITHROMYCIN | 250MG/5ML | FOR SUSPENSION / ORAL | 2007-08-30 | 3a93d1ddd44b… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clarithromycin | CLARITHROMYCIN | REMEDYREPACK INC. | 9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c6 | 2026-06-24 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Sportpharm LLC | de33ba3a-9df1-4076-8d5f-b603d2698096 | 2026-04-17 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Solaris Pharma Corporation | 4d42821d-ce7a-7d64-e063-6294a90a0875 | 2026-04-09 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | 88c7ded8-333c-408d-b693-a72881710f59 | 2026-04-01 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Preferred Pharmaceuticals Inc. | 81c0c69e-b1ae-42f3-9e85-09b8daa75d8d | 2026-03-30 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Major Pharmaceuticals | d0a66646-6774-4fc6-9b26-a98c3a5df274 | 2026-03-26 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | American Health Packaging | 59ebe6cb-c830-45c7-8242-52f9f42a90a0 | 2026-03-19 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Solaris Pharma Corporation | 4d4303f8-88dd-8b88-e063-6394a90ab48f | 2026-03-17 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | American Health Packaging | fa69ea92-0b41-43fb-918f-ed80e0dedf04 | 2026-03-04 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | A-S Medication Solutions | fad1e5a3-59f9-4868-9937-d3b061ab8f00 | 2026-02-19 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | AvPAK | 1920f943-bbf1-cfd9-7475-96a35680a9e0 | 2026-02-11 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Northwind Health Company, LLC | 471f638a-9dd1-09d3-e063-6294a90a2d4f | 2026-01-08 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Northwind Health Company, LLC | f98aacb4-2f01-3e94-e053-6294a90a9aa0 | 2026-01-01 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| CLARITHROMYCIN | CLARITHROMYCIN | Chartwell RX, LLC | dea5bd78-7f93-4bc4-a2e4-1b021f5fe098 | 2025-12-10 | Warnings, Adverse reactions | CLARITHROMYCIN CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Proficient Rx LP | 9eb306e0-ccfb-418c-82ca-204f20a788f7 | 2025-11-01 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | 1d328f5d-73c1-4df7-a3df-71d0e0221181 | 2025-10-17 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | 1cb8a78a-0f07-49e8-a23e-a77628006209 | 2025-10-16 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | 0be243c6-de02-45dd-8210-cab1bbc8dfa7 | 2025-10-15 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | Direct_Rx | 3ba1da51-ba5b-323f-e063-6294a90a0333 | 2025-09-08 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
| Clarithromycin | CLARITHROMYCIN | PD-Rx Pharmaceuticals, Inc. | ba216276-b0bd-420a-9e0d-090bdfcc2460 | 2025-08-05 | Warnings, Adverse reactions | Clarithromycin CLARITHROMYCIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.